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Telemedicine for Children With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT05087303
Recruitment Status : Recruiting
First Posted : October 21, 2021
Last Update Posted : March 14, 2023
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Seethal Jacob, MD, MS, Indiana University

Study Description
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Brief Summary:
The purpose of this study is to learn more about how the use of two different types of telemedicine (distance medical care) can address barriers to receiving comprehensive sickle cell care, and whether care can be improved. Aim 1: Adapt two telemedicine models (i.e., hub-and-spoke; direct-to-consumer) for use with children with SCD using caregiver input from our preliminary K12 work. Aim 2: Demonstrate the feasibility of the telemedicine models developed in Aim 1 as the models undergo successive stakeholder refinement during use in actual clinical care. Aim 3: Evaluate the effectiveness of the refined models from Aim 2 in a pre/post study by assessing (a) process of care measures, (b) provider satisfaction, (c) caregiver/patient-centered outcomes, and (d) clinical outcomes and healthcare utilization.

Condition or disease Intervention/treatment Phase
Anemia, Sickle Cell Other: Types of Telemedicine Delivery Models Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Telemedicine for Pediatric Sickle Cell Patients in Medically Underserved Areas
Actual Study Start Date : September 21, 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Telehealth

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Hub and Spoke Other: Types of Telemedicine Delivery Models
Each arm delivers standard sickle cell care using a different model based on patient location.
Active Comparator: Direct to Consumer Other: Types of Telemedicine Delivery Models
Each arm delivers standard sickle cell care using a different model based on patient location.


Outcome Measures
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Primary Outcome Measures :
  1. Measuring adherence to appointment in sickle cell care. [ Time Frame: 1 year ]
    Failed appointments in Electronic Medical Record - no more than one failed appointment during pilot year.

  2. Measuring adherence to lab draws in sickle cell care. [ Time Frame: 6 months ]
    Adherence to lab draws - a minimum of one complete blood count per six months.

  3. Measuring healthcare utilization pre and post telemedicine participation. [ Time Frame: 1 year ]
    Will determine the frequency of 1) vasoocclusive pain episode; 2) acute chest syndrome; 3) Emergency department visits; 4) hospitalizations. This data will be collected through chart abstraction from Electronic Medical Record one year prior to study entry and one year on study.

  4. Measuring collaboration of primary care provider and subspecialty care provider. [ Time Frame: 1 year ]
    Documentation of Primary Care Provider communication of visits in the electronic medical record at least 70% of the time.

  5. Provider Feedback [ Time Frame: 1 year ]
    Telemedicine Acceptance Questionnaire (TAQ) - will be given to all providers participating in telemedicine visits after every telemedicine visit. 0-5 Likert scale

  6. Caregiver feedback [ Time Frame: 1 year ]
    Telemedicine satisfaction survey (TESS) - administered to caregivers following each telemedicine visit. 0-5 Likert scale


Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be between 0 to 21 years old with Sickle Cell Disease and receive care at the Riley Hospital for Children Comprehensive Sickle Cell Disease clinic.
  • The family must be willing to receive their care using the telemedicine model available to them based on the location of their primary residence.
  • TeleSCD model participants must live within 1 hour of the pre-identified telemedicine sites, while VirtualSCD model participants must live within the city limits of the pre-identified area.

Exclusion Criteria:

  • If a patient receives chronic transfusion therapy, they will not be eligible to participate, as our telemedicine models will not support this.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05087303


Contacts
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Contact: Seethal Jacob, MD 317-278-9662 seejacob@iu.edu

Locations
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United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Seethal Jacob, MD    317-278-9662    seejacob@iu.edu   
Sponsors and Collaborators
Indiana University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Seethal Jacob, MD Indiana University
More Information
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Responsible Party: Seethal Jacob, MD, MS, Assistant Professor of Pediatrics, Indiana University
ClinicalTrials.gov Identifier: NCT05087303    
Other Study ID Numbers: 2101344406
1K23HL143162-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: March 14, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn